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Caring for Providers to Improve Patient Experience Study Phase 2 in Migori County (CPIPE2)

Primary Purpose

Maternal Health, Mental Health, Healthcare Provider

Status
Active
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Training
Peer support and mentorship
Leadership engagement
Embedded champions
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Maternal Health focused on measuring providers, mental health, unconscious bias, prejudice, Kenya, stress, burnout, person-centered care, quality of care, discrimination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Providers working in maternity units of the intervention facilities are all eligible.

Exclusion Criteria:

  • Inability to attend scheduled training.

Sites / Locations

  • Migori County hospital and sub-county hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Control arm

Arm Description

Training: The investigators will develop a training for providers that addresses the following topics: Stress & positive coping mechanisms; Unconscious bias awareness and mitigation; Person-centered maternity care; Dealing with difficult situations; and Teamwork and communication; Peer support and mentorship: The investigators will identify what works best for these groups in terms of group composition, size, and how the groups want to interact. Leadership engagement: To ensure leadership buy in, support and sustainability of the intervention, the investigators will engage leadership of the County. Embedded champions: To facilitate ongoing engagement, the investigators will identify local leaders, and invite them to training where they will be taught how to facilitate peer support groups and serve as champions.

Will not receive any training during the intervention period

Outcomes

Primary Outcome Measures

Change in Perceived Stress Scale (PSS) score from Baseline to 6 Months
The Perceived Stress Scale (PSS) score ranges from 0 to 40 with higher scores indicating higher perceived stress.
Change in Shirom-Melamed Burnout Measure (SMBM) score from Baseline to 6 Months
The Shirom-Melamed Burnout Measure range from 1 to 7 with higher scores indicating higher burnout
Change in stress knowledge and attitudes score from Baseline to 6 Months
The stress knowledge and attitudes score is measured by 14 survey questions with scores ranging from 0 to 14. Higher scores indicate higher knowledge and positive attitudes regarding stress and stress management
Change in unconscious bias knowledge and attitudes score from Baseline to 6 Months
The unconscious bias knowledge and attitudes score is measured by 17 survey questions with scores ranging from 0 to 17. Higher scores indicate higher knowledge and positive attitudes regarding unconscious bias and unconscious bias mitigation

Secondary Outcome Measures

Change in hair cortisol levels from Baseline to 6 Months
There are no specified cut-offs for cortisol levels, but, on average, higher cortisol levels indicate higher stress
Change in Heart Rate Variability (HRV) levels from Baseline to 6 Months
There are no specified cut-offs for HRV but, on average, lower HRV scores indicate higher stress
Change in socioeconomic status-person centered maternity care implicit association test (IAT) score
IAT scores vary between -2 and +2. For this study, higher positive scores indicates a stronger implicit association between high status with good patient and low status with difficult patient
Change in explicit bias scores from baseline to 6 months
The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias

Full Information

First Posted
August 18, 2021
Last Updated
October 6, 2022
Sponsor
University of California, San Francisco
Collaborators
Kenya Medical Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05019131
Brief Title
Caring for Providers to Improve Patient Experience Study Phase 2 in Migori County
Acronym
CPIPE2
Official Title
Addressing Provider Stress and Unconscious Bias to Improve Quality of Maternal Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
June 24, 2022 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Kenya Medical Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e. care that is respectful and responsive to women's needs, preferences, and values. The investigators focus on health provider stress and unconscious bias because they are key drivers of poor-quality care that are often not addressed in interventions designed to improve quality of maternal health care. The investigators plan to (1) design an intervention that enables providers to identify and manage their stress and unconscious bias; (2) pilot the intervention to assess its feasibility and acceptability; and (3) assess preliminary effect of the intervention on: (a) provider knowledge, attitudes, and behaviors related to stress and unconscious bias; and (b) provider stress levels.
Detailed Description
Poor person-centered maternal health care (PCMHC) contributes to high maternal and neonatal mortality in sub-Saharan Africa (SSA), and disparities in PCMHC are driving disparities in use of maternal health services., However, little research exists on how to improve PCMHC and reduce disparities. The investigators seek to fill this gap with this project. They propose targeting health provider stress and unconscious bias as fundamental factors driving both poor PCMHC and disparities in PCMHC. Health care provider stress and unconscious bias are important to consider because: (1) providers in low-resource settings often work under very stressful conditions; (2) unconscious bias is prevalent in every society including SSA; and (3) these factors are mutually reinforcing drivers of poor quality care and disparities in person-centered care. In the first phase of the project (CPIPE1), they conducted research to examine (1) the factors associated with PCMHC and identified provider stress and unconscious bias as key contributing factors. They also examined the levels of provider stress and unconscious bias and the types of stressors and biases in Migori County, Kenya. The results of that research will be used to inform this phase (CPIPE2), the aims of which are to: (1) design a multicomponent theory and evidence-based intervention that enables providers to identify and manage their stress and unconscious bias; (2) pilot the intervention to assess its feasibility and acceptability; and (3) assess preliminary effect of the intervention on: (a) provider knowledge, attitudes, and behaviors related to stress and unconscious bias; and (b) provider stress levels using a pretest-posttest control group design. They will use the results of the pilot to refine the intervention and develop an R01 proposal for a multi-site evaluation with a larger sample and longer follow up to assess impact on PCMHC. This study will yield valuable information to inform quality improvement efforts for PCMHC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Health, Mental Health, Healthcare Provider, Adverse Outcomes, Stress, Stress, Psychological, Stress, Emotional, Quality of Care, Burnout, Discrimination, Social
Keywords
providers, mental health, unconscious bias, prejudice, Kenya, stress, burnout, person-centered care, quality of care, discrimination

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Training: The investigators will develop a training for providers that addresses the following topics: Stress & positive coping mechanisms; Unconscious bias awareness and mitigation; Person-centered maternity care; Dealing with difficult situations; and Teamwork and communication; Peer support and mentorship: The investigators will identify what works best for these groups in terms of group composition, size, and how the groups want to interact. Leadership engagement: To ensure leadership buy in, support and sustainability of the intervention, the investigators will engage leadership of the County. Embedded champions: To facilitate ongoing engagement, the investigators will identify local leaders, and invite them to training where they will be taught how to facilitate peer support groups and serve as champions.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Will not receive any training during the intervention period
Intervention Type
Behavioral
Intervention Name(s)
Training
Intervention Description
trainings to reduce conscious bias and stress
Intervention Type
Behavioral
Intervention Name(s)
Peer support and mentorship
Intervention Description
facilitated peer and mentorship opportunities
Intervention Type
Behavioral
Intervention Name(s)
Leadership engagement
Intervention Description
Engaged leadership at the county and facility levels
Intervention Type
Behavioral
Intervention Name(s)
Embedded champions
Intervention Description
Facilitate local champions to promote intervention
Primary Outcome Measure Information:
Title
Change in Perceived Stress Scale (PSS) score from Baseline to 6 Months
Description
The Perceived Stress Scale (PSS) score ranges from 0 to 40 with higher scores indicating higher perceived stress.
Time Frame
Baseline and 6 months
Title
Change in Shirom-Melamed Burnout Measure (SMBM) score from Baseline to 6 Months
Description
The Shirom-Melamed Burnout Measure range from 1 to 7 with higher scores indicating higher burnout
Time Frame
Baseline and 6 months
Title
Change in stress knowledge and attitudes score from Baseline to 6 Months
Description
The stress knowledge and attitudes score is measured by 14 survey questions with scores ranging from 0 to 14. Higher scores indicate higher knowledge and positive attitudes regarding stress and stress management
Time Frame
Baseline and 6 months
Title
Change in unconscious bias knowledge and attitudes score from Baseline to 6 Months
Description
The unconscious bias knowledge and attitudes score is measured by 17 survey questions with scores ranging from 0 to 17. Higher scores indicate higher knowledge and positive attitudes regarding unconscious bias and unconscious bias mitigation
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in hair cortisol levels from Baseline to 6 Months
Description
There are no specified cut-offs for cortisol levels, but, on average, higher cortisol levels indicate higher stress
Time Frame
Baseline and 6 months
Title
Change in Heart Rate Variability (HRV) levels from Baseline to 6 Months
Description
There are no specified cut-offs for HRV but, on average, lower HRV scores indicate higher stress
Time Frame
Baseline and 6 months
Title
Change in socioeconomic status-person centered maternity care implicit association test (IAT) score
Description
IAT scores vary between -2 and +2. For this study, higher positive scores indicates a stronger implicit association between high status with good patient and low status with difficult patient
Time Frame
Baseline and 6 months
Title
Change in explicit bias scores from baseline to 6 months
Description
The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Providers working in maternity units of the intervention facilities are all eligible. Exclusion Criteria: Inability to attend scheduled training.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patience Afulani, PhD, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Migori County hospital and sub-county hospitals
City
Migori
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
No
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Caring for Providers to Improve Patient Experience Study Phase 2 in Migori County

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